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Related Studies
Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
This study has been completed.

First Received on February 14, 2002.   Last Updated on December 13, 2009   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030823
  Purpose

RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.


Condition Intervention Phase
Breast Cancer
Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine
Biological: QS21
Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y, TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet hemocyanin plus QS21 induces an antibody response against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:

    • Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy

      • May or may not have elevated CA 15-3 or CEA levels
    • Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels

      • Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart

        • For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart
    • Stage III and completed adjuvant therapy no more than 24 months ago
    • Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy
    • Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection
    • Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago
    • Stage IV that is stable on hormonal therapy
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Lymphocyte count at least 500/mm^3
  • WBC at least 3,000/mm^3

Hepatic:

  • AST no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 1.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No clinically significant New York Heart Association class III or IV cardiac disease

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior seafood allergy
  • No known prior immunodeficiency or autoimmune disease
  • No other active cancer except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 6 weeks since prior immunotherapy
  • No prior vaccine with any of the antigens in this study

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior surgery
  • Concurrent surgery for local recurrence allowed if patient remains disease free
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030823

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Teresa Ann Gilewski, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Armstrong JL, Ragupathi G, Powell S, et al.: Preliminary data of vaccination of high risk breast cancer (BC) patients (pts) with a heptavalent antigen: keyhole limpet hemocyanin (KLH) conjugate plus the immunologic adjuvant QS-21. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-675, 2003.

ClinicalTrials.gov Identifier: NCT00030823     History of Changes
Other Study ID Numbers: CDR0000069200, MSKCC-01019, NCI-H01-0084
Study First Received: February 14, 2002
Last Updated: December 13, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Keyhole-limpet hemocyanin
QS 21
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012